Drug Interaction Statin
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndromes
Intervention: BMS-919373 (Drug); Rosuvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
This purpose of this study is to assess the effects of BMS-919373 on the single dose
Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.
Clinical Details
Official title: A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of BMS-919373 on the Single-dose Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Maximum observed plasma concentration (Cmax) of Rosuvastatin and AtorvastatinArea under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin
Secondary outcome: Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and AtorvastatinTerminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin Safety based on results of physical examinations, vital sign measurements, ECGs, 24-hour telemetry, clinical laboratory tests, and physical measurements and will also include the incidence of AEs, SAEs and AEs leading to discontinuation
Detailed description:
Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of
Rosuvastatin and Atorvastatin in healthy subjects
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
For more information regarding BMS clinical trial participation, please visit
www. BMSStudyConnect. com.
Inclusion Criteria:
- Signed Written Informed Consent form
- Healthy subjects as determined by no clinically significant deviation from normal in
medical and surgical history, physical examination, physical measurements, vital
signs, 12-lead ECG, 24-hour telemetry, and clinical laboratory tests
- Body mass index (BMI) of 18. 0 to 32. 0 kg/m2, inclusive
- Men and women, ages 18 to 55 yrs, inclusive
Exclusion Criteria:
- Current or history of cardiovascular diseases, including arrhythmias, coronary heart
disease, and congestive heart failure
- Current or history of symptomatic hypotension
- Current or history of liver diseases, including cirrhosis and liver failure
- Current or history of kidney diseases, including nephrotic syndrome, renal failure,
nephrolithiasis, and urolithiasis
- Current or history of neurological diseases, including presyncope, syncope,
convulsive disorders such as epilepsy, cerebral thrombosis and cerebral embolism,
transient ischemic attack, and stroke; or mental disorders Exceptions for
presyncope/syncope related to vasovagal responses are allowable at the discretion of
the investigator
- History of significant head injury in the last 2 years
Locations and Contacts
Additional Information
Starting date: March 2014
Last updated: August 13, 2014
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